We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental health problems.
Mental health problems in youth are a global problem, causing incalculable suffering in youth and families, harming long-term prospects of youths, and are creating substantial economic costs to society. Existing treatments are not fully addressing these problems because they focus on a subset of mental health problems; they are limited in efficacy; and are not provided to most youth in need. Transdiagnostic digital treatments that address mechanisms underlying mental health problems, such as emotion regulation, have been called for to address these problems. As an initial pilot study we will include 60 participants aged 12-17 years and their parents in a randomized controlled feasibility trial comparing a 6-week Primary care Online Emotion-regulation Treatment (POET) to a 6-week active Supportive Treatment (ST). Both interventions will be delivered in blended format combining online therapist-supported treatment modules with a video-link session. The primary study aims are to examine the feasibility and acceptability of study protocol and treatment protocols. Preliminary utility of the experimental condition will be evaluated by youth-reported, parent-reported, and clinical-reported outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Please see description of experimental arm (arm one)
Please see description of active comparator arm (arm two)
Gustavsberg's Vårdcentral
Stockholm, Sweden
Completion of assessments
Completion of follow-up will be defined as completing at least one clinical outcome at end of intervention.
Time frame: End of treatment 6 weeks after baseline
The fraction of eligible participants who consent to inclusion and randomization
We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomized persons.
Time frame: End of treatment 6 weeks after baseline
Compliance
Compliance with the experimental intervention will be defined as completing at least three of six modules/sessions.
Time frame: End of treatment 6 weeks after baseline
Child version or the Cognitive Emotion Regulation Questionnaire as explorative primary clinical outcome
Measure of emotion regulation
Time frame: Change from baseline, once every week during treatment (0-6 weeks after baseline)
Revised Child Anxiety and Depression Scale as explorative primary clinical outcome
Measure of anxiety and depression symptoms
Time frame: Change from baseline, once every week during treatment (0-6 weeks after baseline)
Children's Global Assessment Scale
Measure of global functioning
Time frame: Change from baseline, 6 weeks after treatment starts
Strengths and Difficulties Questionnaire
Measure of youth strengths and difficulties
Time frame: Change from baseline, 6 weeks after treatment starts
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Brief 16-item Version of the Difficulties In Emotion Regulation
Measure of difficulties in emotion regulation
Time frame: Change from baseline, 6 weeks after treatment starts
Emotion Regulation Questionnaire Child/Adolescents Version
Measure of difficulties in cognitive reappraisal and suppression
Time frame: Change from baseline, 6 weeks after treatment starts
Beliefs About Emotions Questionnaire
Measure of beliefs about emotions
Time frame: Change from baseline, 6 weeks after treatment starts
Emotion Regulation Diversity Index
Measure of emotion regulation flexibility
Time frame: Change from baseline, 6 weeks after treatment starts